AEON AETH060Recalls & reported problems
Lexington Medical, Inc. · Endoscopic Stapler Handle Plus Short · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851574008769), received between Mar 4, 2024 and Jun 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Retraction Problem2
- Firing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Retraction Problem; Firing Problem
THE AEON¿ ENDOSCOPIC STAPLER CONSISTS OF A HANDLE AND RELOAD. DURING A DISTAL PANCREATECTOMY PROCEDURE, AN AETH060 HANDLE WAS USED ALONG WITH AN UNSPECIFIED RELOAD. AFTER THE FIRING, STAPLES WERE MALFORMED AND THE SURGEON WAS UNABLE TO RETRACT THE DEVICE. THE TISSUE WAS ABLE TO BE CLIPPED AND REMOVED FROM THE RELOAD. NO ADDITIONAL SURGERY WAS NECESSARY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670753 ↗MalfunctionMar 4, 2024Retraction Problem; Retraction Problem
THE AEON ENDOSTAPLER SYSTEM CONSISTS OF A HANDLE AND RELOAD. DURING A THORACIC WEDGE RESECTION PROCEDURE., THE SURGEON WAS NOT ABLE TO OPEN THE RELOAD AFTER FIRING. THE RELOAD HAD TO BE REMOVED WITH SOME SURROUNDING TISSUE. SINCE AN ADDITIONAL INCISION WAS REQUIRED TO REMOVE THE TISSUE AND THE SURGERY WAS DELAYED, THIS INCIDENT IS BEING REPORTED IN ABUNDANCE OF CAUTION. NO PATIENT HARM. SURGEON HAD DESCRIBED THE TISSUE AS FIBROTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18827121 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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